Events

Recall of CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00536-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00536-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Baxter is providing additional information regarding correct device use and additional warnings to end users. the improper use of peritoneal dialysis (pd) transfer sets could result in contamination leading to infection or peritonitis. there is also the potential of thyroid dysfunction following iodine exposure in children and infants. the current ifu does not list this as a warning.
  • Action
    Baxter is providing additional information regarding correct device use and additional warnings to end users. This action has been closed-out on 01/02/2016.

Device

CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twi...
  • Model / Serial
    CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long)CAPD Solution Transfer Set with Locking ConnectorProduct code: 5C4160Minicap Extended Life PD Transfer Set with Twist ClampProduct code: 5C4482, R5C4482Extra Short product code: 5C4483, R5C4483Extra Long product code: R5C4484ARTG Number: 167416
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd